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SOP 403: Initial Review – Criteria for IRB Approval

Version: C0325

PURPOSE

The University of Utah Institutional Review Board (IRB) must ensure all regulatory criteria are met before approval is to conduct research is granted.

SCOPE

This policy applies to non-exempt human subject research conducted at the University of Utah.

POLICY

All research proposals involving human subjects must meet specific criteria before study-related procedures can begin. These criteria are based on three core principles from the Belmont Report: respect for persons, beneficence and justice. All regulatory criteria must be met, including any applicable state or local laws. In addition, unique criteria specific to the University of Utah and the VA Salt Lake City Healthcare System (VASLCHCS) may also apply and must be met. To ensure all regulatory criteria and additional requirements are met, the University of Utah IRB uses a checklist system.

The criteria for approval and other applicable requirements are outlined in the board member checklist. Assigned IRB reviewers must complete this checklist to ensure that all approval criteria and requirements are met.

More detailed information about the approval criteria and other requirements is provided according to specific topics. Board members may access supplemental guidance on the University of Utah IRB website or on the University of Utah Electronic Research Integrity and Compliance Administration system (ERICA).

 

Please contact the IRB Office at (801) 581-3655 or irb@hsc.utah.edu for additional guidance.